Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars

NCT ID: NCT01789346

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.

Detailed Description

Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.

Conditions

Scar; Surgical Scar; Cicatrix; Cicatrix, Hypertrophic; Keloid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

532nm KTP

Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser

Group Type: OTHER

532nm KTP

Intervention Type: DEVICE

up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.

595nm PDL

Cynosure Cynergy 595nm pulsed-dye (PDL) laser

Group Type: ACTIVE_COMPARATOR

595nm PDL

Intervention Type: DEVICE

up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.

Interventions

532nm KTP

up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.

Intervention Type: DEVICE

595nm PDL

up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.

Intervention Type: DEVICE

Other Intervention Names

ExcelV laser; Cutera ExcelV; Excel V; Cynosure Cynergy; Cynergy laser

Eligibility Criteria

Inclusion Criteria

• Fitzpatrick Skin Type I - IV
• Has postoperative linear scar(s) which is one to twelve months post-surgery.
• Having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length.
• Be in good health.
• Must agree not to undergo any other procedure for the treatment of scar during the study.
• Willing to refrain from excess sun exposure and willing to wear sunscreen on the treated scar during the study (including the follow-up period).
• Able to read, understand and sign the Informed Consent Form.
• Willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions.
• Willingness to have digital photographs taken of the treated scar.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria

• Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
• Having received any prior treatment for the target surgical scar.
• Pregnant and/or breastfeeding.
• Significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy.
• Current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medication.
• History of abnormal or delayed wound healing, keloid formation or pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• History of malignant skin disease, immune deficiency disorders, coagulation disorders, seizure disorders due to light, or diseases stimulated by heat, unless prophylactic measures taken prior to treatment.
• Systemic use of isotretinoin within 6 months or corticosteroids within 12 months of study participation.
• Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• Current smoker or history of smoking within 12 months of study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina Alster, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Institute of Dermatologic Laser Surgery

Elizabeth Tanzi, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Institute of Dermatologic Laser Surgery

Locations

Washington Institute of Dermatologic Laser Surgery

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

C-12-EV03

Identifier Type: -

Identifier Source: org_study_id